Pharmaceutical industry committed to finding a solution to Ebola

NEW YORK — The pharmaceutical industry has committed considerable resources to developing both vaccines and treatments to address the current Ebola crisis. “Protecting patients and their families from the devastating effects of Ebola is a national priority," stated John Castellani, president and CEO for the Pharmaceutical Research and Manufacturers of America, in speaking to the selection of Ron Klain to manage the U.S. government’s response to preventing the spread of the Ebola virus. "[O]ur industry stands ready to support these efforts by using our resources and expertise to assist patients and their families affected."

Johnson & Johnson on Wednesday announced that it has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company is closely collaborating with the World Health Organization and the National Institute of Allergy and Infectious Diseases, as well as other key stakeholders, governments and public health authorities on the clinical testing, development, production and distribution of the vaccine regimen.

The vaccine regimen combines a Janssen preventative vaccine with a vaccine from Bavarian Nordic, a biotechnology company based in Denmark. This combination vaccine regimen has shown promising results in preclinical studies, and is now planned to be tested for safety and immunogenicity in healthy volunteers in Europe, the United States of America and Africa starting in early January. Janssen is targeting production of more than one million doses of the vaccine regimen in 2015, 250,000 of which are expected to be released for broad application in clinical trials by May 2015.

“We are urgently working to provide our vaccine expertise, production capabilities, our people and resources to address the Ebola crisis,” stated Alex Gorsky, chairman and CEO, Johnson & Johnson. “Our innovation model enables us to quickly mobilize our extensive resources to collaborate with health authorities and governments and other experts to help contain this disease, save lives, and protect the health and lives of those at risk."

GlaxoSmithKline is also quickly developing an Ebola vaccine. "Development of the vaccine candidate is progressing at an unprecedented rate, with first phase 1 safety trials with the vaccine candidate underway in the U.S., U.K. and Mali, and further trials due to start in the coming weeks," the company stated. "Initial data from the phase 1 trials are expected by the end of the year and if successful, the next phases of the clinical trial programme will begin in early 2015 which will involve the vaccination of thousands of frontline healthcare workers in the three affected countries – Sierra Leone, Guinea and Liberia."

And on Tuesday Tekmira Pharmaceuticals provided an update on its Ebola program. The company is reporting it has commenced limited GMP manufacture of a new therapeutic specifically targeting the Ebola – Guinea variant, which is the viral variant responsible for the Ebola epidemic currently prevalent in West Africa. Supply of this new product will be available in early December, 2014, for potential use by various collaborators.

"The genomic sequence of the Ebola virus responsible for the current outbreak in West Africa has been determined from several viral isolates," the company stated. "[Tekmira] has completed the design of a modified RNAi therapeutic specifically targeting this viral variant, now termed 'Ebola-Guinea.'"

The Food and Drug Administration has authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to patients with confirmed or suspected Ebola virus infections. The current supply of TKM-Ebola inventory is limited. However, Tekmira intends to continue to provide TKM-Ebola, if requested, to patients with confirmed or suspected Ebola virus infections under this regulatory framework. To date, several patients have been treated with the product and data collected will be provided to the FDA under the Company's Investigational New Drug Application. "We have established a similar framework with Health Canada for the potential use of TKM-Ebola for patients with confirmed or suspected Ebola virus infections," Tekmira added.

Through the stories of skin cancer survivors, Olay educated women about daily sun protection by stressing the importance of wearing a facial moisturizer with a minimum SPF 15 every day. The message of the campaign has been seen more than two billion times.

"We are so grateful to the Skin Cancer Foundation for recognizing Olay with the Skin Sense Award," stated Lela Coffey, brand director, North America Olay at P&G. "Our mission is to empower women everywhere to never settle and to be their best beautiful. We recognize we have not only the opportunity, but responsibility to continue a dialogue around skin cancer prevention, which we will do through joint efforts with The Skin Cancer Foundation."

Hillary Fogelson, a four-time survivor, who served as the face of the campaign, shared her story and easy tips for daily protection.

The goal of the campaign, along with the brand's work with the Skin Cancer Foundation, is to reduce the incidence of skin cancer. In the United States, more than five million skin cancer cases are treated every year.

Olay embarked on this mission to affect change that hinged on not only educating women, but also providing them with the products to care for their skin. Olay did this by reinforcing the message that sunscreen should not be restricted to only the beach or pool – it must be applied daily.

Coffey and Fogelson were present at the event, along with Perry Robins, president and founder of the Skin Cancer Foundation, to present Olay with the Skin Sense Award.

FDA to survey pharmacists on their experiences with changes in generic drug pill appearance

SILVER SPRING, Md. — The Food and Drug Administration last week announced plans to survey pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.

The agency expressed a concern that generic drugs that differ in appearance from the brand-name equivalent, or from one another, may lead to nonadherence. "Studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs' physical appearances, leading to harmful clinical and public health consequences, as well as increased healthcare costs from avoidable morbidity and mortality," the agency stated.

"To provide additional information that may help guide regulatory policy or pharmacy business practices, we intend to conduct surveys of pharmacists and patients about their perceptions about and experiences with generic drug product pill appearance change. These surveys are intended to further our understanding of the relationship between changes in pill appearance and nonadherence to prescribed therapeutic regimens," the agency continued. "The surveys may enable us to investigate factors that may explain the association between changes in pill appearance and nonadherence, including which factors could be modified to improve the safe and effective use of generic drugs."

According to the agency, generic drugs make up approximately 85% of all human prescription drugs prescribed in the United States.

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